A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a randomized, parallel group, double-blind Phase 2 study with a 52-week blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 35
Healthy Volunteers: f
View:

• Participants who meet the criteria of T1D according to American Diabetes Association

• Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).

• Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy

‣ one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or

⁃ continuous subcutaneous insulin infusion (CSII)

• Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:

‣ Glutamic acid decarboxylase (GAD-65)

⁃ Insulinoma Antigen-2 (IA-2)

⁃ Zinc-transporter 8 (ZnT8) or

⁃ Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)

• Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit.

• Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.

• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Locations
United States
California
University of California San Francisco - Mission Bay- Site Number : 8400012
RECRUITING
San Francisco
Colorado
University of Colorado- Site Number : 8400003
RECRUITING
Denver
Florida
University of Florida College of Medicine- Site Number : 8400010
RECRUITING
Gainesville
University of Miami Hospital- Site Number : 8400013
RECRUITING
Miami
AdventHealth Orlando- Site Number : 8400002
RECRUITING
Orlando
Idaho
Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009
RECRUITING
Idaho Falls
Illinois
NorthShore University HealthSystem - Skokie- Site Number : 8400007
RECRUITING
Skokie
Massachusetts
Joslin Diabetes Center - Boston- Site Number : 8400015
RECRUITING
Boston
North Carolina
University of North Carolina at Chapel Hill- Site Number : 8400001
RECRUITING
Chapel Hill
New York
University at Buffalo - Downtown Campus- Site Number : 8400004
RECRUITING
Buffalo
Ohio
Cincinnati Children's Hospital Medical Center- Site Number : 8400019
RECRUITING
Cincinnati
Pennsylvania
The Children's Hospital of Philadelphia Site Number : 8400005
RECRUITING
Philadelphia
Texas
University of Texas - Southwestern Medical Center- Site Number : 8400011
RECRUITING
Dallas
Washington
Benaroya Research Institute at Virginia Mason- Site Number : 8400016
RECRUITING
Seattle
Other Locations
Belgium
Investigational Site Number : 0560002
RECRUITING
Brussels
Investigational Site Number : 0560001
RECRUITING
Leuven
Canada
Investigational Site Number : 1240007
RECRUITING
London
Investigational Site Number : 1240003
RECRUITING
Montreal
Investigational Site Number : 1240004
RECRUITING
Montreal
Investigational Site Number : 1240005
RECRUITING
Montreal
Investigational Site Number : 1240001
RECRUITING
Vancouver
Denmark
Investigational Site Number : 2080005
RECRUITING
Herlev
Finland
Investigational Site Number : 2460003
RECRUITING
Tampere
France
Investigational Site Number : 2500004
RECRUITING
Corbeil-essonnes
Investigational Site Number : 2500005
RECRUITING
Mont-de-marsan
Investigational Site Number : 2500006
RECRUITING
Paris
Investigational Site Number : 2500007
RECRUITING
Pontoise
Investigational Site Number : 2500003
RECRUITING
Saint-herblain
Germany
Investigational Site Number : 2760003
RECRUITING
Dresden
Investigational Site Number : 2760001
RECRUITING
Hanover
Investigational Site Number : 2760002
RECRUITING
Oldenburg In Holstein
Investigational Site Number : 2760004
RECRUITING
Ulm
Hungary
Investigational Site Number : 3480001
RECRUITING
Balatonfüred
Investigational Site Number : 3480004
RECRUITING
Budapest
Investigational Site Number : 3480002
RECRUITING
Nyíregyháza
Investigational Site Number : 3480006
RECRUITING
Székesfehérvár
Italy
Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003
RECRUITING
Florence
IRCCS Ospedale San Raffaele-Site Number : 3800006
RECRUITING
Milan
Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009
RECRUITING
Naples
Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001
RECRUITING
Novara
Investigational Site Number : 3800005
RECRUITING
Novara
Investigational Site Number : 3800007
RECRUITING
Rome
Investigational Site Number : 3800008
RECRUITING
Torette
Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002
RECRUITING
Varese
Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004
RECRUITING
Verona
Poland
Investigational Site Number : 6160008
RECRUITING
Bialystok
Investigational Site Number : 6160002
RECRUITING
Katowice
Investigational Site Number : 6160005
RECRUITING
Lodz
Investigational Site Number : 6160009
RECRUITING
Szczecin
Investigational Site Number : 6160001
RECRUITING
Warsaw
Investigational Site Number : 6160004
RECRUITING
Warsaw
Investigational Site Number : 6160006
RECRUITING
Warsaw
Investigational Site Number : 6160007
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Investigational Site Number : 7240001
RECRUITING
Barcelona
Investigational Site Number : 7240002
RECRUITING
Esplugues De Llobregat
Investigational Site Number : 7240004
RECRUITING
Málaga
Investigational Site Number : 7240005
RECRUITING
Oviedo
Investigational Site Number : 7240003
RECRUITING
Seville
Investigational Site Number : 7240006
RECRUITING
Valencia
Investigational Site Number : 7240007
RECRUITING
Vitoria-gasteiz
Sweden
Investigational Site Number : 7520002
RECRUITING
Solna
Investigational Site Number : 7520001
RECRUITING
Stockholm
Investigational Site Number : 7520003
RECRUITING
Stockholm
United Kingdom
Investigational Site Number : 8260003
RECRUITING
Birmingham
Investigational Site Number : 8260007
RECRUITING
Birmingham
Investigational Site Number : 8260001
RECRUITING
Cambridge
Investigational Site Number : 8260009
RECRUITING
Dundee
Investigational Site Number : 8260010
RECRUITING
Glasgow
Investigational Site Number : 8260006
RECRUITING
Harrow
Investigational Site Number : 8260004
RECRUITING
Leicester
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2028-10-27
Participants
Target number of participants: 192
Treatments
Experimental: Frexalimab Dose 1
Experimental: Frexalimab Dose 2
Experimental: Frexalimab Dose 3
Placebo_comparator: Placebo
Matching Placebo
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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